Caprelsa (vandetanib)

Caprelsa tablets contain the active ingredient vandetanib, which is a type of medicine known as a protein kinase inhibitor. It works by interfering with the pathways that signal certain cancer cells to grow.

04/11/2013

What is it used for?

To treat aggressive medullary thyroid cancer that is causing symptoms and cannot be removed by surgery or has spread to other parts of the body.

How does it work?

Caprelsa tablets contain the active ingredient vandetanib, which is a type of medicine known as a protein kinase inhibitor. It works by interfering with the pathways that signal certain cancer cells to grow.

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The way that cells in the body work and grow is regulated by various enzymes called protein kinases. These enzymes can be found in certain receptors on the surface of cells that are involved in the growth and spread of cancer cells.

In cancerous cells, the kinases make the cells grow and multiply abnormally. They also stimulate nearby blood vessels to grow into the tumour. The new blood vessels allow the cancer cells to grow and multiply by supplying them with oxygen and nutrients. They also allow the cancerous cells to spread into other areas of the body through the blood circulation.

Vandetanib works by attaching to a certain protein inside the cancer cells and blocking the action of a protein kinase. This stops the signals that tell the cancer cells to grow and multiply. It also stops blood vessels growing into the tumour. This reduces the tumour’s blood supply and with it, its supply of oxygen and nutrients. Both these effects stop the tumour from growing.

Caprelsa may also act directly on cancer cells to kill them or slow down their growth.

How do I take it?

The usual dose is one 300 mg tablet taken once daily. However, it is important to follow the instructions given by your doctor. If you experience side effects your dose may be reduced.

The tablets should be taken at the same time each day. They can be taken either with or without food.

If you forget to take a dose at your usual time and it is more than 12 hours until your next dose is due, then take the missed dose. If you forget to take a dose and it is less than 12 hours until your next dose is due then don’t take the missed dose, just take your next dose as usual. Don't take a double dose to make up for a missed dose.

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Warning!

You will be given a patient alert card with this medicine. This contains important information about this medicine that you should read, as well as details of your medicines and doses. You should show this card to any healthcare professional that is treating you.

Avoid exposing your skin to sunlight, sunlamps or sunbeds while taking this medicine, as it may increase the sensitivity of your skin and increase the chance of you getting sunburnt. You should use a sun cream or wear clothing to protect the skin if you are going out in the sun.

Your heart function will be checked with an electrocardiogram (ECG) before you start treatment with this medicine. This test should be repeated regularly to monitor your heart and make sure this medicine is not affecting it.

Diarrhoea is a very common side effect of this medicine. You may be given an anti-diarrhoeal medicine such as loperamide to help manage this. It is important to drink plenty of fluids or use rehydration salts to avoid getting dehydrated if you get diarrhoea. Follow the advice given by your doctor. Your doctor may also want you to have more frequent blood tests and ECGs to monitor your heart if you get severe diarrhoea.

You will need to have regular blood tests to monitor the levels of electrolytes (salts such as potassium, magnesium and calcium) in your blood while you are taking this medicine. The levels of thyroid stimulating hormone in the blood will also be monitored. These blood tests will be carried out before treatment is started, and at one, three, six and twelve weeks after starting treatment. After this regular blood tests will be carried out every three months and after any dose changes or treatment interruption.

Your blood pressure should also be regularly monitored while you are taking this medicine.

This medicine could be harmful to a developing baby. Women who could get pregnant must use a reliable method of contraception to avoid getting pregnant, both during treatment with this medicine and for a further four months after treatment is stopped. Seek further medical advice from your doctor. Tell your doctor immediately if you think you could be pregnant during treatment.

Your ability to get pregnant or father a child may be affected by treatment with this medicine. It is important to discuss fertility with your doctor before starting treatment.

Not to be used in

People with a history of a type of irregular heartbeat called Torsades de Pointes, unless the cause of this is known and has been addressed.

People with an abnormal heart rhythm seen on a heart monitoring trace (ECG) as a 'prolonged QT interval'.

People taking medicines that can cause a 'prolonged QT interval' (see end of page for examples).

This medicine is not recommended for children and adolescents under 18 years of age, as the manufacturer has not studied its safety and effectiveness in this age group.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

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This medicine is likely to be harmful to a developing baby. It should not be used during pregnancy unless considered essential by your doctor, and only if the potential benefits outweigh the potential risks to the unborn baby. Seek further medical advice from your doctor.

Women who could get pregnant should use effective contraception to prevent pregnancy, both during treatment, and for at least four months after treatment is finished. Seek further medical advice from your doctor.

If you do get pregnant or want to plan a pregnancy while taking this medicine it is important to consult your doctor straight away for advice.

It is not known if this medicine passes into breast milk, but it could be harmful to a nursing infant if it does. Mothers who need treatment with this medicine should not breastfeed. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)

Diarrhoea. See warning section above. Persistent and severe diarrhoea may lead to dehydration, low blood potassium and kidney failure, particularly if you receive other chemotherapy treatments at the same time.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

Problems in the gut, for example appendicitis, diverticulitis, perforation or obstruction of the gut or inability to control the bowel (faecal incontinence).

Abnormal colour of urine.

Delayed healing of wounds.

Convulsions.

Swelling of the brain.

Nerve disorder known as posterior reversible encephalopathy syndrome (PRES). Signs may include headache, feeling sick or vomiting, sight changes, feeling confused or fits. It is important to tell your doctor straight away if you get these symptoms.

A type of lung problem called interstitial lung disease. You should consult your doctor if you experience shortness of breath or difficulty breathing, a non-productive cough and deterioration in your general health (eg weight loss, fever, fatigue) while taking this medicine.

Serious skin reaction called Steven’s Johnson syndrome. Tell your doctor if you get a widespread rash, blistering or peeling of your skin while you are taking this medicine.

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The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

There is an increased risk of abnormal heart rhythms as a result of a change in the electrical activity in the heart (prolonged QT interval on a heart monitoring trace or ECG) if this medicine is used in combination with other medicines that can have this side effect. These include the following medicines; they should not be taken in combination with vandetanib:

The following medicines may reduce the amount of vandetanib in your blood, which could make it less effective. The manufacturer recommends that these are avoided while you are having treatment with this medicine:

carbamazepine

phenytoin

rifampicin

the herbal remedy St John's wort (Hypericum perforatum).

The following medicines used to reduce the acidity in the stomach may reduce the absorption of vandetanib from the gut. As they could make the vandetanib less effective, these medicines should be avoided where possible during your treatment:

antacids for indigestion or heartburn

H2 antagonists, eg cimetidine, ranitidine

proton pump inhibitors, eg omeprazole, lansoprazole.

Your doctor may want to do extra monitoring if you take any of the following medicines in combination with vandetanib:

ciclosporin

clarithromycin

dabigatran

digoxin

itraconazole

metformin

ritonavir

tacrolimus

warfarin.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain vandetanib as the active ingredient.

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